HPLC测定利可君原料药中主药含量和有关物质  

Study on Determination of Leucogen and Its Related Substance by HPLC

作　　者：郑修文[1] 钱文[1] 高瑞银[2] 杭太俊[1] 张正行[1] 

机构地区：[1]中国药科大学药物分析教研室,南京210009 [2]江苏吉贝尔药业有限公司,江苏镇江212009

出　　处：《中国药学杂志》2006年第14期1105-1108,共4页Chinese Pharmaceutical Journal

摘　　要：目的 研究HPLC测定利可君原料药和有关物质的方法。方法 采用Phenomnex Luna C18色谱柱（4．6mm×250mm，5μm）；以水-乙腈-冰醋酸（62：38：0．3）为流动相；流速1．0mL·min^-1；检测波长210nm，外标法（以4种非对映异构体峰面积之和计）测定利可君含量，峰面积归一化方法测定有关物质。结果 利可君的线性范围为2．0～200mg·L^-1，r=0．9997；检出限为0．50mg·L^-1；最低定量限为2．0mg·L^-1；利可君在流动相溶液中6h内稳定，精密度良好。结论 本法简便，快速，准确，可适用于利可君原料药含量和有关物质的测定。OBJECTIVE To establish a HPLC method for the determination of leucogen and its related substance.METHODS A Phenomnex lama C18（4.6 mm×250 mm, 5μm） was used with a mobile phase consisting of water-acetonitrile-glacial acetic acid（62：38：0.3）. The detection wavelength was 210 nm and the flow rate was 1.0 mL·min^-1. The quantitative determination of leucogen was performed with external standard method using total area of its four diastereomers, and its related substance was determined by normalization method. RESULTS The linearity of the determination by HPLC was over the range of 2.0 - 200 mg·L^-1 ; the correlation coefficient was 0.999 7; the LOD was 0.50 mg·L^-1; the LOQ was over the range of 2.0 mg·L^-1; the sample solution was stable within 6 h; the precision was good. CONCLUSION The HPLC assay and related substance test method is simple and accurate.

关 键 词：利可君 非对映异构体 有关物质 高效液相色谱法 

分 类 号：R927[医药卫生—药学]